Health solutions company Perrigo Company plc (NYSE:PRGO) (TASE:PRGO) and its development and manufacturing partner Catalent jointly reported on Monday the receipt of approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application for generic albuterol sulfate inhalation aerosol for the treatment or prevention of bronchospasm.
The US Food and Drug Administration (FDA) has approved Perrigo's abbreviated new drug application for generic albuterol sulfate inhalation aerosol, the first AB-rated generic version of ProAir HFA.
Following the US FDA approval, Perrigo will now market a limited quantity of generic albuterol sulfate inhalation aerosol and, in partnership with its development and manufacturing partner Catalent, will increase the production to meet future demand.
Generic albuterol sulfate inhalation aerosol is indicated in patients four years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
For the previous 12 months, ProAir HFA gross sales were approximately USD1.4bn, as measured by IQVIA.
Apotex launches Teriparatide Injection in US
Teva Pharmaceuticals secures FDA approval for generic Forteo (teriparatide injection)
Upsher-Smith Laboratories introduces Pitavastatin Tablets
Par Pharmaceutical starts shipping colchicine 0.6mg capsules
Padagis launces Brinzolamide Ophthalmic Suspension with CGT exclusivity
Novartis completes Sandoz Spin-off
Novartis completes Sandoz spin-off, focusing on innovative medicines
Sanofi and Teva collaborate on innovative IBD treatment
Hikma marks KLOXXADO two-year anniversary by surpassing 375,000 doses donated in the US
STADA seeks full approval for Kinpeygo in IgA nephropathy from UK MHRA
Azurity Pharmaceuticals completes Slayback Pharma acquisition
Sandoz secures European approval for Tyruko biosimilar in MS treatment
Senores Pharmaceuticals introduces Nicardipine Hydrochloride Capsules USP, 20mg and 30mg in US
Lupin collaborates with Mark Cuban Cost Plus Drug Company and COPD foundation
Certara Simcyp receives FDA grants for advanced pharmacokinetic modelling